MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-04 for CLINITEK STATUS 10332185 manufactured by .
[3550425]
Customer reported that a multistix 10sg dipstick read erroneously as a mutlistix pro 10lb dipstick on the instrument. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[10782736]
The customer has been re-trained for proper sampling technique. Customer has also been offered software that will flag this error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00089 |
| MDR Report Key | 3159160 |
| Report Source | 07 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-05-15 |
| Date Added to Maude | 2013-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | NORTHERN RD. CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY, SUFFOLK MA CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS |
| Generic Name | CT STATUS |
| Product Code | JIR |
| Date Received | 2013-06-04 |
| Catalog Number | 10332185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-04 |